FDA News

The FDA has granted approval to enfortumab vedotin plus pembrolizumab for patients with locally advanced or metastatic urothelial cancer.

The FDA has approved belzutifan to treat patients with advanced renal cell carcinoma (RCC) who have already undergone PD-1 or PD-L1 inhibitor and a VEGF tyrosine kinase inhibitor.

Eflornithine (Iwilfin) received FDA approval to reduce the risk for relapse in pediatric and adult patients with high-risk neuroblastoma, making it the first therapy to reduce risk for relapse in children with the disease.

A priority review of nivolumab plus cisplatin-based chemotherapy as a frontline treatment option for adult patients with unresectable or metastatic urothelial carcinoma is underway.

The FDA has approved the non-covalent BTK inhibitor, pirtobrutinib, to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have already undergone 2 lines of therapy.

There have been reports of T-cell malignancies among patients who have undergone CD19- or BCMA-directed autologous CAR T-cell immunotherapies.

The FDA has approved nirogacestat as a treatment for adults with progressing desmoid tumors based off findings from the phase 3 DeFi trial.

The FDA has expanded the indication for enzalutamide to include patients with high-risk nonmetastatic castration-sensitive prostate cancer.

The FDA has approved capivasertib plus fulvestrant to treat patients with locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations.

Repotrectinib is now available to treat adults with advanced or metastatic non-small cell lung cancer that harbors a ROS1 fusion.

The PD-L1 IHC 22C3 pharmDx diagnostic tool will help identify patients with gastric or gastroesophageal junction adenocarcinoma whose disease expresses PD-L1 and who are thereby eligible for pembrolizumab.

The FDA has restricted the indication for gastric cancer to only include patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test.

Lisocabtagene maraleucel is under consideration as a potential treatment option for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA has approved fruquintinib to treat adults with metastatic colorectal cancer.

The FDA has approved pembrolizumab in combination with chemotherapy as a treatment for patients with locally advanced unresectable or metastatic biliary tract cancer.

The FDA has approved toripalimab, with cisplatin and gemcitabine, and as a monotherapy, to treat adults with nasopharyngeal carcinoma.

Ivosidenib, a targeted therapy, has been approved for patients with relapsed or refractory myelodysplastic syndromes and an IDH1 mutation.

The FDA has approved entrectinib to treat pediatric patients ages 1 month and older with NTRK-positive solid tumors.

The FDA has approved tests to identify patients with metastatic non–small cell lung cancer who are eligible for treatment with encorafenib plus binimetinib.

The FDA has granted priority view to osimertinib plus chemotherapy based on data from the phase 3 FLAURA2 trial.

The FDA has approved pembrolizumab with platinum-containing chemotherapy for patients with resectable non–small cell lung cancer, in both the neoadjuvant and adjuvant setting.

The FDA has approved adjuvant nivolumab to treat completely resected stage IIB/C melanoma.

The FDA has approved encorafenib plus binimetinib to treat adults with metastatic non-small cell lung cancer with a BRAF V600E mutation.

The approval of FoundationOne CDx as a companion diagnostic for selpercatinib seeks to broaden access to therapies for patients with RET fusion–positive solid tumors.

The FDA has granted marketing authorization to the Invitae Common Hereditary Cancers Panel, which can detect multiple genetic variants associated with hereditary cancers.

The FDA has granted priority review to odronextamab for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.

The FDA has approved bosutinib to treat pediatric patients with Philadelphia chromosome–positive, chronic-phase chronic myelogenous leukemia.

The FDA has granted belzutifan priority review designation based on data from the phase 3 LITESPARK-005 trial.